Serum Cytokine Levels in Patients with Lumbal Disc Herniation and Effectiveness of Exercise

Serum Cytokine Levels in Patients with Lumbal Disc Herniation with and Without Neurological Deficits and Effectiveness of Exercise

The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Lumbal stabilization excercises; Other: Conventional exercises

Detailed Description

The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06030
      • Faculty of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for patients with disc herniation:

• Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
• not an indication for lumbar disc herniation surgery
• for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
• pain intensity of VAS ≥ 3
• male and female patients between the ages of 20-55

Inclusion Criteria for heathy people

• not having low back pain complaints in the past
• female and male healthy individuals between the ages of 20-55

Exclusion Criteria:

• systemic or inflammatory disease
• pregnant or breastfeeding women
• surgery of lumbar region
• fracture of lumbar vertebrae
• lumbar scoliosis
• medication use for psychiatric disorders
• tumor
• allergy
• neurological disease
• alcohol-drug use
• generalized musculoskeletal pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The stabilization group; The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.	Other: Lumbal stabilization excercises; The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
Experimental: The general exercise group; The general exercise group will perform conventional exercises 3 times a week during 6 weeks.	Other: Conventional exercises; The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
No Intervention: The control group; Individuals in the control group will not be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory cytokines	Tnf-alfa , IL-6, IL-4, IL-1β, Beta-endorphins, Anandamide, Arachidonoylgylycerol will be evaluated with ELISA kit.	6 weeks

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Birgül Morkoç, PhD student, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Low back pain; Disc herniation; Cytokines; Stabilization exercises; General exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: KA-20040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Non are planned to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No